CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

All Clinical Trials for Polyethylene Glycol 3350 And Electrolytes

Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation

Completed

Orion Corporation, Orion Pharma

Phase 4

2008-01-01

The aim of the study is to show that new polyethylene glycol (PEG) solution without
electrolytes is as effective in the treatment of constipation as PEG solution with
electrolytes in the elderly institutionalized people. Also, the tolerability and the safety
of the study drug will be examined.

A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for
colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets
Phosphosoda) are now used on a limited basis because of their known association with renal
injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely)
has been used for over two decades for colon cleansing. The mixture is not very palatable
due to the electrolyte additives which include sodium sulfate.
To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons
worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not
mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of
Gatorade. Conservatively, we estimate that 25% of colonoscopies in the US are being done
with this prep. Anecdotally there have been reports (case series) that it is far more
palatable and the prep is equally efficacious. The active ingredient, PEG, is not changed
and therefore this is not surprising. The issue at present is that there has never been a
blinded study to confirm these claims.
This study will compare the efficacy of the two preps. There is no funding. The
investigators will charge insurance companies for the prep - this is our current practice.
The procedures will be done on healthy individuals referred for colon cancer screening and
the exam will be billed to their insurance. There will be no patient honorarium. The
investigators will check electrolytes to be sure patients do not develop hypokalemia with
the Gatorade prep.

The primary objective of the study was to evaluate the proportion of subjects with a bowel
movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of
treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus
Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses
of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported
BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM
control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.
In addition, the proportion of subjects with a BM (without straining and without hard and/or
lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E
was evaluated for the time to first BM.

This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that
of prucalopride in the treatment of chronic constipation in females. A total of 240 patients
will be randomly allocated to treatment with one or the other agent. The study consists of a
14-day run-in period, with treatment subsequently administered for 28 days on a daily basis.
During the study, patients will fill in a stool diary, samples of faeces will be collected,
and colonic transit time will be measured prior to therapy, and from days 22 to 28 of
treatment. The proportion of patients with normalised bowel movements (three or more
spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will
be compared between treatments.

Once the lab test is positive for c. diff, the investigators will order the patient to have
PEG 3350 solution, one 8oz glass every ten minutes until 6 liters are gone, but if still not
clear 2 more liters may be ordered. At enrollment, the treatment arm will have an order for
500 cc Normal saline to be given I.V. The patient will continue with antibiotic treatment as
well. The investigators will plan to check c. diff tests daily to see when they become
negative. The investigators will perform chart audit/review to track mortality, the length
of stay, ICU days, surgical intervention, and APACHE scores (assessment of disease
severity). Chart audit will be used to collect data on their diet and how they feel using a
visual analog scale (collected by nursing staff daily as a standard procedure; see attached
pain scale). Using chart audit, the investigators will record whether the patient is
immunocompromised or not.

Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy

Withdrawn

Medical College of Wisconsin

N/A

2014-06-01

This will be a 4-way comparison to prospectively evaluate the efficacy and patient
tolerability of four commercially available bowel preparations among patients undergoing
colonoscopy for screening and surveillance in a single tertiary academic medical center.

Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome

Not yet recruiting

Tecnoquimicas S.A

N/A

2015-09-01

Objective: The primary objective of this study is to assess the quality of life of people
treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging
procedures, according to the outcome variables reported by patients.
Type of study: A non-interventional observational analytic prospective cohort study.
Sample: We will include people who need bowel cleansing for the realization of imaging tests
Exposures: - oral sodium phosphate normal regimen
- Oral sodium phosphate with modified diet
- Polyethylene Glycol + electrolytes
Follow-up time: 8 days after the bowel preparation
Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium,
Potassium, Calcium)

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